Hightide Therapeutics Inc · HKEX:2511
Hightide Therapeutics — Investor Presentation (2026)
44 slides from Hightide Therapeutics's investor presentation, 2026
Slide 1: HighTide Therapeutics
HighTide Therapeutics 2511.HK 2026
Slide 2: Disclaimer & Forward-Looking Statements
Dr. Liu Disclaimer & Forward-Looking Statements This document is provided by HighTide Therapeutics, Inc. (the “Company”, or “the Group”) for informational purposes only. The contents of this document have not been reviewed by any regulatory authority. This document has not been independently verifie
Slide 3: HighTide Therapeutics – Recent Selected Milestones
HighTide Therapeutics – Recent Selected Milestones H2H vs. Dapagliflozin Appointed CMO NDA Accepted People’s Daily Interview Completion of Industry Recognition Placement HTD1801 Demonstrated Greater HighTide Therapeutics Advances Completion of Placing of New Three academicians and other Glycemic Con
Slide 4: HighTide Therapeutics – Development Plan
HighTide Therapeutics – Development Plan CKM Indications Expansion HTD1801 Commercialization HTD1801 Evolving from T2DM to a comprehensive Cardiovascular-Kidney-Metabolic therapy Commercialization China Phase III clinical trials completed. NDA accepted. CKD CKM Clinical Data Support: Post hoc analys
Slide 5: Company Overview
( 1 ) Company Overview
Slide 6: Company Overview — Innovative Drug Development for CKM
Dr. Liu Company Overview — Innovative Drug Development for CKM • Focus on Cardiovascular-Kidney-Metabolic (CKM) diseases, inheriting the legacy of traditional Chinese natural products and pioneering original innovation. • HTD1801 is a first-in-class new molecular entity with dual mechanisms of actio
Slide 7: Leading CKM Innovation
Leading CKM Innovation The global CKM market continues to expand as clinical consensus evolves and demand for integrated care grows, making multi-potent therapies increasingly competitive. 458 2023 - 2026: Rapid Evolution of CKM Guidelines Key Global CKM Characteristics Treatment Market 204 & Consen
Slide 8: Farxiga (Dapagliflozin - SGLT-2) – A Global Blockbuster Built on a Validated Innovation Paradigm
Farxiga (Dapagliflozin - SGLT-2) – A Global Blockbuster Built on a Validated Innovation Paradigm 2024 Global SGLT-2 Inhibitor Sales: Farxiga - Strong Revenue Growth Driven by Multi-Organ Benefits Key Indications’ Approval Milestones $16.8 Bn USD 9000 8,405 8000 7,717 2022 2021 NMPA-CKD 7000 5,963 FD
Slide 9: Pipeline Overview – Innovation-Driven Growth
Pipeline Overview – Innovation-Driven Growth T2DM NDA Accepted; Continued Advancement of Clinical Development Across CKM-Related Indications Candidate Mechanism/Target Indication Right Designations Pre-Clinical Phase I Phase II Phase III T2DM Three Phase III clinical trials completed in Mainland Chi
Slide 10: Elite Global Management Team – CKM Strategy Focus
Elite Global Management Team – CKM Strategy Focus Strong R&D Capabilities World-Renowned Expert Team Seasoned Commercial Team R&D team: World-class scientists (chemistry, biology, World-renowned expert team and KOLs: Core members: Rich experience in commercialization & pharmacology, medicine). Parti
Slide 11: Introduction to Clinical Development Progress of Core Pipeline
Introduction to Clinical Development 2 Progress of Core Pipeline
Slide 12: HTD1801 – A Global First-in-Class Drug
HTD1801 – A Global First-in-Class Drug Biologically Found Active Moieties Novel Molecular Entity Berberine HTD1801 HTD1801’s unique microstructure enhances solubility and lipophilicity, enabling dual active centers to release synergistically — maximizing efficacy and safety. Ursodeoxycholic Acid HTD
Slide 13: HTD1801 Acts on Core Drivers of CKM via Two Complementary Mechanisms
HTD1801 Acts on Core Drivers of CKM via Two Complementary Mechanisms HTD1801 is a novel molecular entity with a unique dual mechanism of action, exerting its effects through the AMPK–NLRP3 axis, with the potential to deliver comprehensive benefits for CKM patients, including glycemic and lipid impro
Slide 14: HTD1801 – A Multi-Mechanistic Driver of Metabolic Homeostasis
HTD1801 – A Multi-Mechanistic Driver of Metabolic Homeostasis Potential for One-Drug, Comprehensive Treatment Benefits Favorable Efficacy and Safety Profile Multiple Therapeutic Benefits Improved insulin resistance and significantly Reduced LDL-C, non-HDL-C, TG reduced blood glucose levels Glyce
Slide 15: Expanding Indications Across CKM – Validating “One Drug, Multiple Benefits”
Expanding Indications Across CKM – Validating “One Drug, Multiple Benefits” T2DM CKD • Preclinical studies demonstrate improvement in renal • Data from 2 SYMPHONY trials published (24-weeks & 52-weeks). biomarkers and histopathology. • Post hoc analysis of SYMPHONY studies demonstrate • Phase III tr
Slide 16: Chronic Kidney Disease (CKD) Pipeline
Chronic Kidney Disease (CKD) Pipeline HTD1801 has the potential to improve eGFR trajectory and restore renal function in early-stage CKD patients. From “attenuating disease progression” to “reversal and restoration”, HTD1801 demonstrates a differentiated advantage in CKD treatment. Conference Highli
Slide 17: Obesity Pipeline
Obesity Pipeline HTD1801 disrupts the vicious cycle of “insulin resistance → metabolic imbalance → fat accumulation → inflammation” through a unique synergy of energy-metabolism modulation and anti-inflammatory effects, offering a novel strategy to overcome current treatment bottlenecks. Clinical Tr
Slide 18: Unlocking HTD1801’s Commercial Potential & Building Long-Term CKM Value
Unlocking HTD1801’s Commercial Potential & Building Long-Term CKM Value Core Commercialization Pillars Authoritative LEK Analysis Peak Sales Forecast (T2DM - China) Robust Clinical Data: Delivers Top-Tier Consultancy: Independent 5 comprehensive, multi-organ benefits commercial modeling conducted by
Slide 19: Key Investment Highlights
( 3 ) Key Investment Highlights
Slide 20: HighTide Therapeutics – Key Investment Highlights
HighTide Therapeutics – Key Investment Highlights Lead Asset HTD1801- Differentiated “One Drug, Multiple Benefits” 01 • Dual mechanism (AMPK metabolic regulation + NLRP3 anti-inflammation) delivers comprehensive benefits across glucose, lipids, renal, cardiovascular, hepatic, and anti-inflammatory e
Slide 21: Compilation of Clinical Data (Appendix)
COMPILATION OF CLINICAL DATA (APPENDIX) www.hightidetx.com
Slide 22: T2DM Clinical Trials——SYMPHONY Studies (Placebo-Controlled Trials)
T2DM Clinical Trials——SYMPHONY Studies （Placebo-Controlled Trials）
Slide 23: SYMPHONY-1 Study (HTD1801 as Monotherapy)
SYMPHONY-1 Study (HTD1801 as Monotherapy) NCT06350890 • A multi-center, randomized, double-blind, placebo-controlled, Phase III clinical trial evaluating the efficacy and safety of HTD1801 as Monotherapy in Patients with T2DM Inadequately Controlled with Diet and Exercise Key Entry Criteria Primary
Slide 24: SYMPHONY-2 Study (HTD1801 as an Add-On Therapy to Metformin)
SYMPHONY-2 Study (HTD1801 as an Add-On Therapy to Metformin) NCT06353347 • A multi-center, randomized, double-blind, placebo-controlled, Phase III clinical trial evaluating the efficacy and safety of HTD1801 with T2DM Inadequately Controlled with Metformin Key Entry Criteria Primary Endpoint • Diagn
Slide 25: Primary Endpoint Achieved: Significant and Durable HbA1c Reduction
Primary Endpoint Achieved: Significant and Durable HbA1c Reduction HTD1801 significantly improves HbA1c in patients with T2DM, with a greater decrease observed in those with more severe disease. 0.0 9.5 9.5 9.2% 0.0 -0.3 -0.3 Placebo HTD1801 9.0 9.0 -0.5 8.5% HbA1c（%） -0.5 -0.6 8.5 8.5 -1.5% Mono 8.
Slide 26: HTD1801 Significantly Improves Both Fasting and Postprandial Glucose in T2DM Patients
HTD1801 Significantly Improves Both Fasting and Postprandial Glucose in T2DM Patients Placebo HTD1801 Placebo HTD1801 0.0 0.0 -0.5 -0.5 -1.0 -0.85 -1.5 Mono -1.0 -0.89 -2.0 Therapy -2.5 -1.5 -3.0 -1.54 -3.5 -3.37 -2.0 -4.0 Week 24 Fasting Plasma Glucose Change from 2-hour Postprandial Glucose Change
Slide 27: HTD1801 Significantly Reduces LDL-C and non-HDL-C in T2DM Patients
HTD1801 Significantly Reduces LDL-C and non-HDL-C in T2DM Patients • The lipid-lowering effects observed during the double-blind phase, including significant reductions in LDL-C and non-HDL-C, were also maintained through Week 52. Placebo HTD1801 Placebo HTD1801 Placebo HTD1801 0.0 Placebo HTD1801 0
Slide 28: HTD1801 Significantly Reduces Inflammatory Biomarkers in T2DM Patients
HTD1801 Significantly Reduces Inflammatory Biomarkers in T2DM Patients • HTD1801 treatment led to reductions in key inflammatory biomarkers – gamma-glutamyl transpeptidase (GGT) and high-sensitivity C-reactive protein (hs-CRP) – both of which are associated with cardiovascular risk in patients with
Slide 29: HTD1801 Significantly Increased Insulin Sensitivity in T2DM Patients
HTD1801 Significantly Increased Insulin Sensitivity in T2DM Patients • In both studies, treatment with HTD1801 demonstrated improvements in insulin sensitivity/insulin resistance (Matsuda index/HOMA-IR) compared to placebo. SYMPHONY-1 at week 24 SYMPHONY-2 at week 24 Matsuda Index Change from Baseli
Slide 30: HTD1801 Has Lower Rate of Serious and Cardiovascular AEs than Placebo
HTD1801 Has Lower Rate of Serious and Cardiovascular AEs than Placebo • The 52-week long-term safety and tolerability were favorable and consistent with the double-blind phase. The types and severity of AEs did not increase with continued HTD1801 treatment compared to newly initiated HTD1801 treatme
Slide 31: T2DM Clinical Trial——HARMONY Study (Head-to-Head Trial vs. Dapagliflozin)
T2DM Clinical Trial——HARMONY Study （Head-to-Head Trial vs. Dapagliflozin）
Slide 32: HARMONY Study (Head-to-Head Trial)
HARMONY Study (Head-to-Head Trial) NCT06415773 • A multi-center, randomized, double-blind, active-controlled, Phase III clinical trial evaluating the efficacy and safety of HTD1801 compared with dapagliflozin in adults with T2DM inadequately controlled with metformin Key Entry Criteria Primary Endpo
Slide 33: Primary Endpoint Achieved With Significant Improvement in HbA1c
Primary Endpoint Achieved With Significant Improvement in HbA1c HbA1c (%) HbA1c (%) Change from Baseline Over Time Change from Baseline at Week 24 0.0 Dapagliflozin HTD1801 0.0 Dapagliflozin HTD1801 Change from Baseline -0.5 -0.5 -0.76 -0.91 -0.89 -0.93 -0.77 -1.0 -1.0 -0.93 -0.95 -1.04 -1.12 -1.12
Slide 34: HTD1801 Significantly Reduced LDL-C and non-HDL-C Levels Compared to Dapagliflozin
HTD1801 Significantly Reduced LDL-C and non-HDL-C Levels Compared to Dapagliflozin • After 12 weeks of treatment, HTD1801 led to statistically significant reductions in LDL-C and non-HDL-C from baseline in T2DM patients. In contrast, the dapagliflozin group showed a significant increase in LDL-C and
Slide 35: Significant Reductions in Lp(a) in HTD1801 Treated Patients
Significant Reductions in Lp(a) in HTD1801 Treated Patients Lp(a) at Week 12 Lp(a) at Week 24 Dapagliflozin HTD1801 Dapagliflozin HTD1801 4 4 3.42 3.29 3 3 Change from Baseline Change from Baseline 2 2 Lp(a) (nmol/L) Lp(a) (nmol/L) 1 1 0 0 -1 -1 -2 -2 -3 -3 -4 -3.21 -4 -3.91 • Most commonly used glu
Slide 36: Therapeutic Potential in Chronic Kidney Disease (CKD)
Therapeutic Potential in Chronic Kidney Disease (CKD) (Post hoc Analysis of the SYMPHONY Study)
Slide 37: Pooled Analysis Evaluating the Renal Benefits of HTD1801
Pooled Analysis Evaluating the Renal Benefits of HTD1801 SYMPHONY: Multi-center, Randomized, Double-blind, Placebo-controlled Phase III studies SYMPHONY-1 Double-Blind Open-Label Extension Patients with T2DM inadequately controlled with diet Placebo BID HTD1801 1000 mg BID and exercise 1:2 SYMPHONY-
Slide 38: Early Clinical Data Indicate HTD1801 Significant Improvement in Renal Function in Patients with T2DM
Early Clinical Data Indicate HTD1801 significant improvement in Renal Function in Patients with T2DM Hyperfiltration Subgroup Normal eGFR Subgroup Mild Renal Impairment Subgroup (eGFR ≥1 0 mL/min/1.73m², N=85) (eGFR: 90-120 mL/min/1.73m², N=748) (eGFR: 60-90 mL/min/1.73m², N=123) Subgroup Placebo (N
Slide 39: HTD1801 Sustains eGFR Improvement Over Weeks and After Placebo Crossover
HTD1801 Sustains eGFR Improvement Over 52 Weeks and After Placebo Crossover • HTD1801 treatment for 52 weeks led to a significant eGFR improvement from baseline in patients with mild renal impairment • +3.08 mL/min/1.73 m²; 95% CI: 0.46 - 5.70; P = 0.0217 • An eGFR improvement was also observed foll
Slide 40: HTD1801 Demonstrates No Changes in Potassium or Sodium Levels
HTD1801 Demonstrates No Changes in Potassium or Sodium Levels • Patients in the HTD1801 treatment group maintained stable potassium and sodium levels throughout the study, with a low risk of hyperkalemia or hyponatremia 145 4.5 4.3 143 4.1 141 Mono Therapy 3.9 139 3.7 137 Placebo HTD1801 3.5 135 Bas
Slide 41: Metabolic Dysfunction-Associated Steatohepatitis (MASH) Data of Phase IIa Clinical Trial
Metabolic Dysfunction-Associated Steatohepatitis (MASH) Data of Phase IIa Clinical Trial
Slide 42: Phase IIa Clinical Results in MASH
Phase IIa Clinical Results in MASH • After 18 weeks of treatment with HTD1801, patients with MASH and T2DM achieved significant reductions in liver fat content and improvements in fibrosis. Relative Change in Liver Fat Content cT1 (ms) cT1 (ms) Reduction ≥ 80 ms HTD1801 HTD1801 HTD1801 38.5 Placebo
Slide 43: Well-Recognized by International Academia and Presented at Internationally Renowned Scientific Conferences
Well-Recognized by International Academia and Presented at Internationally Renowned Scientific Conferences ADA 2025 2026 ASN 2025 Late-Breaking Presentation Long-term extension data, head-to- Late-Breaking Presentation: of Phase III SYMPHONY 1 head Phase III results, and combination Evidence of Rena
Slide 44: Well-Recognized by International Academia and Presented at Internationally Renowned Scientific Journals
Well-Recognized by International Academia and Presented at Internationally Renowned Scientific Journals Diabetes Care NEJM Evidence ▪ Published results of the Phase III clinical study for T2DM led by Dr. ▪ Published results of the Phase III clinical study for T2DM led by Dr. Linong Ji as Leading PI